Events

Hercules Patient Lifter 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 R & R Healthcare Equipment Pty Ltd 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    RC-2017-RN-01492-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-12-08
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01492-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • 데이터 추가 비고
  • 원인
    R&r; healthcare identified that the hercules patient lifter, the spreader bar (which holds the sling) is secured to the lifter arm by a lock tighten dome nut. there has been one report of this dome nut becoming loose causing the spreader to detach from the lifter arm, resulting in a client fall.
  • 조치
    R & R Healthcare is advising distributors to inspect stock and ensure the dome nut is tight. A repair kit will be provided for all lifts to be inspected. Users are advised check that the dome nut is tight, and the spreader bar is secured to the lifter arm. The supplier of the lift will be installing an additional locking pin to the lifter.

Device

Hercules Patient Lifter
  • 모델명 / 제조번호(시리얼번호)
    Hercules Patient Lifter Model Number: H150MTSerial Numbers: 2015 07 LFT 005T 001 to 2015 07 LFT 005T 079 and 2015 39 LFT 005T 040 to 2015 39 LFT 005T 066ARTG Number: 224479
  • Manufacturer
    R & R Healthcare Equipment Pty Ltd

Manufacturer

R & R Healthcare Equipment Pty Ltd